Fatima Wazin, PhD
Medical Writer And Regulatory Affairs Associate
Sydney,NSW
Summary
Detail-oriented Medical Writer with 9+ years of research experience. Adept in a Clinical Research Organization (CRO) environment, possessing expertise across diverse therapeutic areas within the medical devices sector. Strong background in regulatory compliance, collaboration, and state government operations. Holds a Ph.D in Medicine from the University of Sydney, and has authored numerous scientific manuscript.
Overview
10
10
years of professional experience
12
12
years of post-secondary education
Work History
Medical Writer and Regulatory Affairs Associate
Avania Pty Ltd
Sydney, NSW
10.2022 - Current
- Analyze, interpret, and organize scientific and statistical data for medical technology development.
- Create technical documentation for regulatory submissions, such as Clinical Evaluation Plans, Reports, Post Market Clinical Follow-up Plans, and Safety and Clinical Performance Summaries.
- Develop clinical documentation, including Ethics Submissions, Clinical Investigation Plans, Study Protocols, Investigator’s Brochures, and Informed Consent Forms.
- Plan and conduct systematic literature reviews, involving literature search, screening, data extraction, and synthesis.
- Prepare journal articles and manuscripts.
- Maintain and review departmental Standard Operating Procedures.
- Collaborate with clients and regulatory bodies, such as the Therapeutic Goods Administration (TGA) and Medsafe (NZ).
Project Officer (Environmental Health)
Environment Protection Authority
Sydney , NSW
12.2021 - 10.2022
- Development and delivery of environmental health projects consistent with government strategies and priorities.
- Proactively managed project risks and executed mitigation strategies.
- Analyzed environmental data to deliver accurate and high-quality scientific reports.
- Enforced compliance with relevant environmental regulations for licensed premises.
- Collaborated with industry, councils, and community groups on environmental regulation and development
Project/Policy Officer (Education)
NSW Government
Sydney, NSW
02.2020 - 12.2021
- Developed comprehensive executive plans, including risk assessment, resource management, and status reporting.
- Contributed to the creation and implementation of the School Success Model Policy, including conducting a high-level impact evaluation study and proposing evidence-based solutions to the School Improvement and Education Reform Group.
- Collaborated with cross-functional stakeholders, including engineers, designers, analysts, and customers.
Senior Administration and Technician
Apple Pty Ltd
Sydney, NSW
08.2014 - 02.2020
- Conducted Apple Certified hardware repairs and diagnostics for iPhone and Mac devices.
- Managed incoming and outgoing repairs in the repair space while ensuring stringent quality control standards.
- Repaired and reestablished positive customer relationships.
- Collaborated with diverse teams, enhancing customer experiences and issue resolution.
- Consistently exceeded customer service expectations in a dynamic retail setting, achieving high satisfaction scores.
Doctoral Researcher
University of Sydney
, NSW
03.2017 - 12.2019
- Conducted and reported novel research in accordance with appropriate ethical, legal and professional frameworks.
- Managed all aspects of the research project, including risk management, animal ethics, and stakeholder meetings.
- Generated creative theories based on quantitative and qualitative research.
- Collaborated, mentored, and networked in the scientific community.
- Authored scientific reports and presented research to the international scientific community.
- Promoted diversity and scientific idea exchange through the Bosch Symposiums and Peer Review podcast.
Education
Doctor of Philosophy - Medicine
University of Sydney
01.2014 - 12.2019
Bachelor of Science - Anatomy And Histology (Honours Class I)
University of Sydney
03.2010 - 11.2014
Diploma of Government -
University of New England
02.2020 - 03.2021
Skills
Medical Device Expertise
Timeline
Medical Writer and Regulatory Affairs Associate
Avania Pty Ltd
10.2022 - Current
Project Officer (Environmental Health)
Environment Protection Authority
12.2021 - 10.2022
Project/Policy Officer (Education)
NSW Government
02.2020 - 12.2021
Diploma of Government -
University of New England
02.2020 - 03.2021
Doctoral Researcher
University of Sydney
03.2017 - 12.2019
Senior Administration and Technician
Apple Pty Ltd
08.2014 - 02.2020
Doctor of Philosophy - Medicine
University of Sydney
01.2014 - 12.2019
Bachelor of Science - Anatomy And Histology (Honours Class I)
University of Sydney
03.2010 - 11.2014
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